MAUDE Adverse Event Report: ABBOTT DIABETES CARE ABBOTT FREESTYLE LIBRE 2; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Model Number LIBRE 2

Device Problem Defective Device (2588)

Patient Problems Hyperglycemia (1905); Hypoglycemia (1912)

Event Date 08/09/2021

Event Type  Injury  

Event Description

I use abbott freestyle libre 2, to read my body worn (arm) abbott freestyle libre 2 sensor.Previously i used abbott freestyle libre and used my cellphone as my reading device thereby eliminating the need for a reader device.Unfortunately fda have yet to provide approval on cell phones being used for reading abbott freestyle libre 2 sensors so i am required to carry on my person the reader.I traveled to (b)(6) on (b)(6) 2021.On (b)(6) 2021 my reader device malfunctioned indicating error code 2.The device suggested i turn the reader off and on or contact customer service.The only button on the device failed to allow me to turn it off and at the time of the incident abbott customer care was closed, so i had to wait until the next day.I was attended to by medical staff at the hotel where i was staying as i had no way to verify my blood glucose level and rely exclusively on this device.While i had brought a back up sensor and test strips for moment in time manual glucose testing, both of these require the reader to be operational.Eventually the device lost power and could provide no assistance to me.Plugging it in to recharge also yielded no success.The following day, tuesday (b)(6), i phoned abbott customer support on (b)(6).I had to call five times due to being hung up on and transferred to the wrong department 3 times.Eventually i spoke to a supervisor named (b)(6) who supposedly reports to a manager named (b)(6), both of whom i was advised work from a (b)(6) location.(b)(6) however, either refused to or was unable to provide any assistance in terms of shipping me a replacement device, nor even advising through abbott (b)(6) counterparts where i could voluntarily go and purchase one.(b)(6) refused to escalate the issue and only on my 3rd request to document my case, did she actually do so.She provided me case number (b)(4).It is of incredible and most serious concern to me that a device i purchased and received in the usa was ostensibly completely disregarded in the context of it being supported due to where i happened to be located at the time of its malfunction.In my view this is not only a seriously negligent illustration of abbott in their failure to take any precautions, nor offer any assistance, but i made abundantly clear to them my willingness to do whatever needed to access their local market options, and, even their refusal to assist shows to me an unconscionable defiance.I required several days of medical intervention.This caused great distress to me physically but also to my family and hotel staff.It is my view that this case highlights a major flaw in any approval process that limits or absolves the manufacturers requirement to ensure support for their us regulated devices is provided irrespective of which jurisdiction they may be when they malfunction.I look forward to a formal reply of fda once you have investigated this incident.Sincerely, (b)(6).Severe hypoglycemia as well as sever hyperglycemia.Frequency: 14 day duration, given into/ under the skin, for 2 years, ongoing blood glucose monitoring.Fda safety report id # (b)(4).

• Brand Name: ABBOTT FREESTYLE LIBRE 2
• Type of Device: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): ABBOTT DIABETES CARE
• MDR Report Key: 12324834
• MDR Text Key: 267243698
• Report Number: MW5103246
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LIBRE 2
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 40 YR
• Patient Weight: 78